JP2008526277A - Intramedullary nail - Google Patents

Intramedullary nail Download PDF

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JP2008526277A
JP2008526277A JP2007548655A JP2007548655A JP2008526277A JP 2008526277 A JP2008526277 A JP 2008526277A JP 2007548655 A JP2007548655 A JP 2007548655A JP 2007548655 A JP2007548655 A JP 2007548655A JP 2008526277 A JP2008526277 A JP 2008526277A
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intramedullary nail
length
range
central axis
nail
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JP5060308B2 (en
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シュランジュ，アンドレ
ブェトラー，マークス
フリッグ，ローベルト
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Synthes GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7283—Intramedullary pins, nails or other devices with special cross-section of the nail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/8635—Tips of screws

Abstract

本発明は髄内釘に関する発明であって、特に脛骨に使用して、髄腔内へ挿入されることに適する近位端部（２）、末端部（３）並びに、中央軸（６）で構成され、前記髄内釘は、 Ａ）範囲が２００〜５００ｍｍの全長Ｌを有し； Ｂ）第１湾曲部（４）は長さＧ１＝Ｌと湾曲半径Ｒ１を有し； Ｃ）第２湾曲部（１３）は長さＧ２＝Ｇ１と湾曲半径Ｒ２＜Ｒ１を有して、近位端部（２）と第１湾曲部（４）の間に設置され；また、 Ｄ）二つの湾曲部（４；１３）で構成される中央部の両端点における接線が９°〜１２°の角度ガンマを形成する。The present invention relates to an intramedullary nail, particularly for the tibia, suitable for being inserted into the medullary cavity with a proximal end (2), a distal end (3) and a central axis (6). Configured, the intramedullary nail A) has a total length L in the range of 200-500 mm; B) the first bending portion (4) has a length G 1 = L and a bending radius R 1 ; C) The second bend (13) has a length G 2 = G 1 and a bend radius R 2 <R 1 and is located between the proximal end (2) and the first bend (4); D) The tangent at both end points of the central portion constituted by the two curved portions (4; 13) forms an angle gamma of 9 ° to 12 °.

Description

発明の詳細な説明Detailed Description of the Invention

本発明は、請求項１に特定される、特に脛骨に用いる髄内釘に関する発明である。   The present invention relates to an intramedullary nail used in particular for the tibia as specified in claim 1.

ゴースニーの米国特許第６，０２０，５０６号明細書は、曲げられる近位端部と；両端の間に設置され、多少湾曲されたセグメントを介して別端部と角度を持つ遠位端部で構成されるジェネリック髄内釘を開示している。さらに、該近位端部は直角に曲げられることで、軸端において接線と中心軸の間に相対的に大きい角度が形成される。相対的に長骨・管状骨、特に脛骨に使用できないことが開示された髄内釘の欠点である。   U.S. Pat. No. 6,020,506 to Goesney has a proximal end that is bent; a distal end that is placed between the ends and angled with another end through a slightly curved segment. A generic intramedullary nail is disclosed. Further, the proximal end is bent at a right angle to form a relatively large angle between the tangent and the central axis at the axial end. It is a disadvantage of the intramedullary nail disclosed that it cannot be used for relatively long bones and tubular bones, particularly tibia.

本発明はある医療製品を提供する。本発明の目的は、多少湾曲される部分で構成される中心部を有して、該中心部の両端点における接線により相対的に小さい角度を形成し、この角度で特に長骨・管状骨に適する髄内釘を得ることである。   The present invention provides a medical product. It is an object of the present invention to have a central portion composed of a slightly curved portion, and to form a relatively small angle by tangents at both end points of the central portion. To get a suitable intramedullary nail.

本発明により、請求項１の特徴を有する髄内釘をもって発明の目的が達成された。   According to the invention, the object of the invention is achieved with an intramedullary nail having the features of claim 1.

本発明により達成される利点は、本発明の髄内釘が以下に述べられる本質から
− 本髄内釘は、二つの湾曲部で構成される一つの中心部と、二つの湾曲が違う半径を有することで、本髄内釘が髄管に最適に順応できて；
− 中間部の端点における接線は９°〜１２°の角度ガンマを囲んで、更に髄内釘は、比較的に真直ぐな管状骨に適し、特に脛骨に最適であって、
− それは角度ガンマが小さいため、髄内釘を無理なくして髄空に挿入できることである。 The advantages achieved by the present invention are based on the essence that the intramedullary nail of the present invention will be described below. The intramedullary nail has one central portion composed of two curved portions and two radii having different radii. By having this intramedullary nail adapts optimally to the medullary canal;
The tangent at the end of the middle part encloses an angle gamma of 9 ° to 12 °, and furthermore the intramedullary nail is suitable for relatively straight tubular bones, especially for the tibia,
-Because the angle gamma is small, the intramedullary nail can be inserted into the spinal cord without difficulty.

明細書によれば、別の実施例おいて髄内釘は下記の際立った特徴を有し、この出願に属する。
− 近位端部の長さＧ３の範囲は１／６Ｌ〜１／３Ｌであって、Ｌは髄内釘の全長である。
− 第１湾曲部の両端点において接線が囲む角度アルファの範囲は７°〜１０°であって、８°〜９°が好ましい。
− 第２湾曲部の両端点において接線が囲む角度ベータの範囲は１°〜３°である。
− 第１湾曲端部は長さＧ１と３００〜１３００ｍｍの湾曲半径Ｒ１を有する。
− 比率Ｌ／Ｒ１の範囲は０.２〜０.８である。
− 末端部の直線長さ“Ｉ”の範囲は０.２０Ｌ〜０.５５Ｌであって、０.２５Ｌ〜０.５０Ｌが好ましい。
− 第１湾曲部の長さＧ１の範囲は０.２Ｌ〜０.４Ｌである。
− 第２湾曲部の湾曲半径Ｒ２の範囲は１０〜５０ｍｍである。 According to the specification, in another embodiment, the intramedullary nail has the following distinguishing features and belongs to this application.
- length range G 3 of the proximal end portion is a 1 / 6L~1 / 3L, L is the total length of the intramedullary nail.
-The range of the angle alpha which a tangent encloses in the both ends of a 1st curved part is 7 degrees-10 degrees, and 8 degrees-9 degrees are preferable.
The range of the angle beta enclosed by the tangent at both end points of the second bending part is 1 ° to 3 °.
- The first curved end portion having a curvature radius R 1 of length G 1 and 300～1300Mm.
The range of the ratio L / R 1 is 0.2 to 0.8.
The range of the linear length “I” at the end is from 0.20 L to 0.55 L, preferably from 0.25 L to 0.50 L.
- length range in G 1 of the first curved portion is 0.2L～0.4L.
- range of curvature radius R 2 of the second curved portion is 10 to 50 mm.

別の実施例において、近位端部は第２湾曲部に軸方向に接して、直線近位部として構成される。   In another embodiment, the proximal end is configured as a straight proximal portion in axial contact with the second curved portion.

別のもう一つ実施例も同様に、遠位端部は直線部で構成されている。   Similarly, in another embodiment, the distal end portion is constituted by a straight portion.

端部の一方または両方ともに直線的構造のため、髄内釘の曲率が小さくなる利点をもたらすことができて、髄内釘が特に長骨、管状骨に適する結果を得る。   Due to the linear structure of one or both of the ends, it can provide the advantage that the curvature of the intramedullary nail is reduced, with the result that the intramedullary nail is particularly suitable for long bones and tubular bones.

別の実施例において、中央軸と同軸である縦のボアホール（ｂｏｒｅｈｏｌｅ）を有する。   In another embodiment, it has a vertical borehole that is coaxial with the central axis.

更に別の実施例において、近位部の範囲内に、中央軸を横断する少なくとも一つの係止孔を有し、螺子の収容に適する。   In yet another embodiment, the proximal portion has at least one locking hole that traverses the central axis and is suitable for screw accommodation.

もう一つの実施例において、遠位端部の範囲内に、同様に中央軸を横断する少なくとも一つの係止孔を有し、螺子の収容に適する。   In another embodiment, there is at least one locking hole within the distal end, also transverse to the central axis, suitable for screw accommodation.

さらに別の実施例において遠位端部の範囲内に、中央軸を横断する二つの係止孔を有し、好ましくは４５°〜９０°である別の角度を形成する。   In yet another embodiment, within the distal end, there are two locking holes crossing the central axis, forming another angle, preferably between 45 ° and 90 °.

別の実施例において、末端部は四つの係止孔を有し、近位にロックされる係止孔から別の二つの係止孔との間隔が異なる。   In another embodiment, the distal end has four locking holes and the spacing between the proximally locked locking hole and the other two locking holes is different.

髄内釘の挿入方法を以下のとおり簡潔に記述する。
− ステップＡ：骨折のタイプに応じて、最善のセッティングを施して、維持する。
− ステップＢ：外科的技術に基づき、開口道具を用いて髄管を開き、挿入角と髄管に対する方向を正しくする。
− ステップＣ：ガイドワイヤーを遠位、随内釘の将来端位に導入し、所要の随内釘の長さを測定する。
− ステップＤ：挿入ハンドルの上に仮止めした随内釘を、ガイドワイヤーを用いて開口チャネルを通して髄腔内へ導入する。
− ステップＥ：随内釘の軸位置のチェックと再調整が済んだあと、随内釘はロッキング部品によりロックされる。 The method of inserting the intramedullary nail is briefly described as follows.
-Step A: Apply and maintain the best settings according to the type of fracture.
-Step B: Based on surgical technique, open the medullary canal with an opening tool and correct the insertion angle and orientation relative to the medullary canal.
-Step C: Introduce a guidewire distally to the future end of the internal nail and measure the required internal nail length.
Step D: Introducing the internal nail temporarily secured on the insertion handle through the open channel into the medullary canal using a guide wire.
Step E: After checking and re-adjusting the axial position of the internal nail, the internal nail is locked by the locking part.

発明の内容および更なる展開を、実施例の一部提示図面をもって以下で詳しく記載する。   The content and further developments of the invention will be described in detail below with the aid of a partial presentation drawing of an embodiment.

図１から図３に示す髄内釘は、基本的に髄腔内へ挿入することに適する中心軸６、近位端部２、遠位端部３と、軸方向に並んで配置された二つの湾曲部４；１３により構成される。近位端部２は、第２湾曲部１３に軸方向で隣接し、真直ぐに構成され、近位部８の長さＧ３≦Ｌである。一方、遠位端部３は長さ“Ｉ”を有する遠位部５により真直ぐに構成される。第１湾曲部４は長さＧ１≦Ｌと湾曲半径Ｒ１を有する。第２湾曲部１３は近位端部２と第１湾曲部４との間に配置され、長さＧ２≦Ｇ１と湾曲半径Ｒ２＜Ｒ１を有する。中央部の両端点における接線ｔ5,4とｔ13,2は両湾曲部４；１３を囲んで、１０°の角度ガンマを形成して、直線・近位部８の中央軸６と近位に、直線・遠位部５の中央軸６と遠位に繋がっている。 The intramedullary nail shown in FIGS. 1 to 3 basically includes a central axis 6, a proximal end 2, and a distal end 3 that are suitable for insertion into the medullary cavity, and are arranged side by side in the axial direction. It comprises two curved parts 4; 13. The proximal end portion 2 is adjacent to the second bending portion 13 in the axial direction, is configured to be straight, and the length G 3 ≦ L of the proximal portion 8 is satisfied. On the other hand, the distal end 3 is configured straight by a distal portion 5 having a length “I”. The first bending portion 4 has a length G 1 ≦ L and a bending radius R 1 . The second bending portion 13 is disposed between the proximal end portion 2 and the first bending portion 4 and has a length G 2 ≦ G 1 and a bending radius R 2 <R 1 . The tangents t 5,4 and t 13,2 at both ends of the central portion surround both curved portions 4; 13, forming an angle gamma of 10 °, and are proximal to the central axis 6 of the straight / proximal portion 8 Further, it is connected to the central axis 6 of the straight / distal part 5 distally.

さらに、第１湾曲部４の両端点における接線ｔ5,4とｔ4,13は、８°の角度アルファを囲み、第２湾曲部１３の両端点における接線ｔ4,13とｔ13,2は２°の角度ベータを囲む。 Further, the tangent t 5,4 and t 4, 13 at both end points of the first bending portion 4 surrounds the angle alpha of 8 °, the tangent t 4, 13 at both end points of the second curved portion 13 t 13, 2 Encloses an angle beta of 2 °.

図面に位置する髄内釘の二つの湾曲は、髄内釘１が移植された後、解剖学的面に適する。つまり、髄内釘が移植されたとき、前後方向に曲る。   The two curvatures of the intramedullary nail located in the drawing are suitable for the anatomical surface after the intramedullary nail 1 has been implanted. That is, when the intramedullary nail is implanted, it bends in the front-rear direction.

さらに、髄内釘は、中央軸６と同軸である連続的な縦のボアホールを有する（図２）。   Furthermore, the intramedullary nail has a continuous vertical borehole that is coaxial with the central axis 6 (FIG. 2).

髄内釘１の近位端部２の範囲内に四つの係止孔９を有して、中央軸６を横断し、中の一つは圧迫に対応できるように細長い穴に構成される。髄内釘１を固定するため、近位端部２の範囲内に五つの螺子（図示せず）が提供される。   It has four locking holes 9 within the proximal end 2 of the intramedullary nail 1 and traverses the central axis 6, one of which is configured as an elongated hole to accommodate compression. Five screws (not shown) are provided within the proximal end 2 to secure the intramedullary nail 1.

末端部３の範囲内に、四つの係止孔１０，１２，１０，１２が中央軸６を横断し、異なる半径方向に配置して、別のと異なる角度を囲む。さらに、中央係止孔１２から別の二つの係止孔１０までの両間隔は異なる。   Within the range of the end 3, four locking holes 10, 12, 10, 12 cross the central axis 6 and are arranged in different radial directions to enclose different angles. Further, the distance between the central locking hole 12 and the other two locking holes 10 is different.

随内釘の実施例を示す長手方向断面図である。It is longitudinal direction sectional drawing which shows the example of an internal nail. 図１のラインＩＩ−ＩＩ間の断面図である。It is sectional drawing between the lines II-II of FIG. 図１、図２で示された髄内釘発明の実施形態における第２湾曲部辺りの拡大断面を示す。The expanded cross section around the 2nd curved part in embodiment of the intramedullary nail invention shown by FIG. 1, FIG. 2 is shown.

Claims (18)

脛骨用の骨髄釘（１）であって、近位端部（２）、遠位端部（３）を有し、髄腔内へ髄内釘を挿入するのに適し、中央軸（６）は、
Ａ）２００〜５００ｍｍの全長Ｌを有し、
Ｂ）第１湾曲部（４）の長さはＧ１≦Ｌであり、湾曲の半径はＲ１であって、
Ｃ）近位端部（２）と第１湾曲部（４）との間に、第２湾曲部（１３）を設けて、その長さをＧ２≦Ｇ１とし、半径はＲ２＜Ｒ１と設定し、
Ｄ）中央部の両端点における接線が二つの湾曲部（４，１３）を含み、９°〜１２°の角度ガンマを形成する
ことを特徴とする脛骨用骨髄釘。 Bone marrow nail (1) for the tibia, having a proximal end (2), a distal end (3), suitable for inserting an intramedullary nail into the medullary cavity, a central shaft (6) Is
A) has a total length L of 200 to 500 mm,
B) The length of the first curved portion (4) is G 1 ≦ L, the radius of curvature is R 1 ,
C) A second bending portion (13) is provided between the proximal end portion (2) and the first bending portion (4), the length thereof is G 2 ≦ G 1 , and the radius is R 2 <R Set to 1 ,
D) A tibial bone marrow nail characterized in that the tangent at both end points of the central part includes two curved parts (4, 13) and forms an angle gamma of 9 ° to 12 °. 近位端部（２）の長さＧ３の範囲が１／６Ｌ〜１／３Ｌであることを特徴とする請求項１に記載の髄内釘（１）。 The intramedullary nail of claim 1, wherein the length range of G 3 of the proximal end (2) is 1 / 6L~1 / 3L (1) . 第１湾曲部（４）の両端点における接線ｔ4,13とｔ1,23とが角度アルファを形成し、その範囲が７°〜１０°、好ましくは８°〜９°であることを特徴とする請求項１または２に記載の髄内釘（１）。 Tangential lines t 4,13 and t 1,23 at both end points of the first curved portion (4) form an angle alpha, and the range is 7 ° to 10 °, preferably 8 ° to 9 °. The intramedullary nail (1) according to claim 1 or 2. 第２湾曲部（１３）の両端点における接線ｔ4,13とｔ13,2とが、１°〜３°の範囲の角度ベータを形成することを特徴とする請求項１〜３のいずれか一項に記載の髄内釘（１）。 The tangent t 4, 13 and t 13, 2 at both end points of the second curved portion (13), any one of the preceding claims, characterized in that to form an angle beta in the range of 1 ° to 3 ° The intramedullary nail (1) according to one item. 近位端部（２）が第２湾曲部（１３）と軸方向に隣接し、長さＧ３≦Ｌである直線部（８）により構成されることを特徴とする請求項１〜４のいずれか一項に記載の髄内釘（１）。 The proximal end (2) is adjacent to the second bending portion (13) in the axial direction and is constituted by a straight portion (8) having a length G 3 ≦ L. The intramedullary nail (1) according to any one of the above. 長さＧ１を有する第１湾曲部（４）が３００〜１３００ｍｍの湾曲半径を有することを特徴とする請求項１〜５のいずれか一項に記載の髄内釘（１）。 First curved portion having a length G 1 (4) is intramedullary nail according to any one of claims 1 to 5, characterized in that it has a curvature radius of 300~1300mm (1). Ｌ／Ｒ１の比率範囲が０.２〜０.８であることを特徴とする請求項１〜６のいずれか一項に記載の髄内釘（１）。 The intramedullary nail (1) according to any one of claims 1 to 6, characterized in that the ratio range of L / R 1 is 0.2 to 0.8. 遠位端部（３）が、長さ“Ｉ”≦Ｌである直線部（５）により構成されることを特徴とする請求項１〜７のいずれか一項に記載の髄内釘（１）。   The intramedullary nail (1) according to any one of the preceding claims, characterized in that the distal end (3) is constituted by a straight part (5) with a length "I" ≤ L. ). “Ｉ”の長さの範囲が０.２０Ｌ〜０.５５Ｌであることを特徴とする請求項８に記載の髄内釘（１）。   The intramedullary nail (1) according to claim 8, characterized in that the range of the length of "I" is 0.20L to 0.55L. “Ｉ”の長さの範囲が０.２５Ｌ〜０.５０Ｌであることを特徴とする請求項８に記載の髄内釘（１）。   The intramedullary nail (1) according to claim 8, characterized in that the range of the length of "I" is 0.25L to 0.50L. 縦のボアホール（７）を設けて、中央軸（６）と同軸にすることを特徴とする請求項１〜１０のいずれか一項に記載の髄内釘（１）。   11. Intramedullary nail (1) according to any one of the preceding claims, characterized in that a longitudinal borehole (7) is provided and coaxial with the central axis (6). 近位端部（２）の範囲内に、少なくとも一つの係止孔（９）を設けて中心軸（６）を横断させることを特徴とする請求項１〜１１のいずれか一項に記載の髄内釘（１）。   The at least one locking hole (9) is provided in the range of the proximal end (2) to traverse the central axis (6), according to any one of the preceding claims. Intramedullary nail (1). 遠位端部（３）の範囲内に、少なくとも一つの係止孔（１０）を設けて中心軸（６）を横断させることを特徴とする請求項１〜１２のいずれか一項に記載の髄内釘（１）。   The at least one locking hole (10) is provided in the region of the distal end (3) to traverse the central axis (6). Intramedullary nail (1). 遠位端部（３）の範囲内に、少なくとも二つの係止孔（１０）を設けて中心軸（６）を横断させることを特徴とする請求項１〜１３のいずれか一項に記載の髄内釘（１）。   14. At least two locking holes (10) are provided in the range of the distal end (3) to traverse the central axis (6). Intramedullary nail (1). 二つの係止孔（１０）が中央軸を横断し、互いに４５°〜９０°までの角度を囲むことを特徴とする請求項１４に記載の髄内釘（１）。   15. Intramedullary nail (1) according to claim 14, characterized in that the two locking holes (10) traverse the central axis and surround each other at an angle of between 45 ° and 90 °. 遠位端部（３）が三つの係止孔（１０，１２，１０）を備えて、中央係止孔（１２）と別の二つの係止孔（１０）との間の両間隔が異なることを特徴とする請求項１〜１５のいずれか一項に記載の髄内釘（１）。   The distal end (3) is provided with three locking holes (10, 12, 10), and the distance between the central locking hole (12) and the other two locking holes (10) is different. Intramedullary nail (1) according to any one of the preceding claims, characterized in that. 第１湾曲部（４）の長さＧ１の範囲が０.２Ｌ〜０.４Ｌであることを特徴とする請求項１〜１６のいずれか一項に記載の髄内釘（１）。 The intramedullary nail according to any one of claims 1 to 16 range of the length G 1 of the first curved portion (4) is characterized in that it is a 0.2L～0.4L (1). 第２湾曲部（１３）の湾曲半径Ｒ２の範囲が１０〜５０ｍｍであることを特徴とする請求項１〜１７のいずれか一項に記載の髄内釘（１）。 The intramedullary nail according to any one of claims 1 to 17 range of curvature radius R 2 of the second curved portion (13) is characterized in that it is a 10 to 50 mm (1).
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